Ceritinib in Asian versus Caucasian patients (Pts) with advanced anaplastic lymphoma kinase (ALK)-rearranged (ALK+) NSCLC: Subgroup analysis of the ASCEND-1 trial.

8078^ Background: Prior results from the first-in-human phase I study (ASCEND-1) of the novel ALK inhibitor (ALKi) ceritinib (LDK378), demonstrated high response rates in crizotinib (CRZ)-naive and CRZ-resistant patients, and established 750 mg/day as maximum tolerated dose. As inter-ethnic variations can lead to differences in treatment response in Asian vs Caucasian pts, we report here a subgroup analysis of the data for pts with ALK+ NSCLC receiving ceritinib at 750 mg/day. Methods: In ASCEND-1, adult pts with advanced ALK+ cancers received oral ceritinib once daily. Investigator assessment of efficacy is presented for pts who received a first dose of ceritinib ≥18 wks prior to the cut-off date (2 Aug 2013). Results: 246 pts with ALK+ NSCLC (82 Asian, 156 Caucasian, 8 other) received ceritinib 750 mg/day with median follow-up of 4.5 months (mos). 67% of patients had received ≥2 prior anticancer therapies. Between Asian and Caucasian pts baseline demographics were similar but ALKi pretreatment had been ...